Needle and suture swaging station

ABSTRACT

A swaging station incorporates a drawing tower that automatically draws, cuts, and inserts an indefinite length strand of suture material within the suture receiving end of a surgical needle for swaging thereof. The suture receiving end of the surgical needle is positioned within a swaging assembly located at the top of the drawing tower that comprises a first fixed swage die and a second movable swage die forming a swage die opening for positively gripping the suture receiving end of the needle positioned therein. A first suture alignment die and a second suture alignment die are precisely registered below and adjacent the respective first and second swage dies to form a lower funnel guide that is axial with the swage die opening for positioning the tip of the suture strand therein. The lower funnel guide has an exit diameter that is larger than the diameter of the suture tip and smaller than the diameter of the suture receiving end of the needle for easy placement of the suture tip therein. Subsequently, the second movable swage die is actuated to swage the suture tip to the needle.

FIELD OF THE INVENTION

The present invention relates generally to machines for automaticallythreading needles, such as surgical needles and the like, and morespecifically, to an apparatus for automatically swaging a length ofsuture material to a surgical needle.

DESCRIPTION OF THE PRIOR ART

The medical products industry presently utilizes semi-automatedprocedures for swaging sutures to surgical needles. For instance, asdescribed in U.S. Pat. No. 3,611,551, manual intervention is required byan operator to accurately position a suture within the suture receivingopening formed in the surgical needle to accomplish swaging thereof.This process is costly in terms of man-hour labor and efficiency becauseof the manual manipulations involved.

Presently, suture material may be supplied wound on a bobbin, or, a kingor driven spool before being cut and positioned within the swaging endof a surgical needle. In U.S. Pat. No. 3,980,177 the suture material isfed from a spool and taken up on a rotating tension rack where uniformlength strands are subsequently cut. Thus, the length of the suture isdetermined by the size of the rack and manual intervention is requiredto change the rack each time a different length of suture is desired.

In U.S. Pat. No. 4,922,904, the suture material is supplied wound on abobbin and is fed through various guide means and a heater forstraightening the material, prior to insertion within the crimpingcavity of the surgical needle. In one embodiment shown therein, anelaborate television monitoring means is required for aligning the drawnsuture within the crimping cavity of the surgical needle prior toswaging thereof. In the same embodiment, a rotary encoder device is usedto determine the length of suture material unwound from the bobbin priorto cutting. In an alternative embodiment, after swaging of theindefinite length of suture material to the needle, the needle-sutureassembly is additionally fed a predetermined distance prior to cuttingto obtain a suture strand of predetermined length. Thus, to obtainuniform lengths of suture material every time requires carefulmanipulations and precise controls, and the processes used to accomplishthese tasks are also costly in terms of man-hour labor and efficiency.

It would be far more desirable to provide a suture cutting system andswaging apparatus that is fully automated and which can automaticallycut uniform lengths of suture material at high-speeds.

It would also be highly desirable to provide a suture cutting systemthat can accurately position suture material within the confines of thesuture receiving openings of surgical needles at an appreciable rate andwithout elaborate techniques or manual intervention.

Also desirable would be to provide a suture cutting system and swagingsystem that is operable under the control of a control system computerthat can provide automatic adjustments to the positions of swage dieswhen different size sutures are swaged to various sized surgicalneedles, and, to adjust for variations when swaging needles of likesize.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the instant invention to provide aneedle threading and swaging station for automatically drawing, cutting,and inserting the tip of a length of suture material within the ends ofa surgical needle for swaging thereof.

It is another object of the instant invention to provide acost-effective automatic needle threading and swaging station thatvirtually eliminates operator exposure to repetitive manual operations.

Furthermore, it is an object of the present invention to provide aneedle threading and swaging station, wherein the needle isautomatically indexed to the swaging station prior to suture insertionand swaging thereof.

Moreover, it is an object of the present invention to provide a needlethreading and swaging station that performs one operation consisting ofdrawing an indefinite length strand of suture material, heating thestrand to stiffen a tip thereof, cutting the strand at a predeterminedlength, and swaging the suture to a surgical needle at the rate oneneedle per second.

These and other objects of the present invention are attained with aswaging station that incorporates a drawing tower that automaticallydraws, cuts, and inserts an indefinite length strand of suture materialwithin the suture receiving end of a surgical needle for swagingthereof. The suture receiving end of the surgical needle is positionedwithin a swaging assembly located at the top of the drawing tower andcomprising a first fixed swage die and a second movable swage dieforming a funnel shaped swage die opening for positioning of the suturereceiving end of the needle therebetween. A first fixed suture alignmentdie and a second movable suture alignment die forms a lower invertedlytapered alignment guide therebetween and axial with the upper alignmentguide for positioning the tip of the suture strand therein. The loweralignment guide has an exit diameter that is larger than the diameter ofthe suture tip and typically equal or smaller than the diameter of thesuture receiving end of the needle to enable accurate placement of thesuture tip therein. Subsequently, the movable swage die is actuatedunder controlled air pressure to swage the suture tip to the needle.

Further benefits and advantages of the invention will become apparentfrom a consideration of the following detailed description given withreference to the accompanying drawings, which specify and show preferredembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram showing the process flow for the needlethreading and swaging system of the present invention.

FIG. 2(a) is a detailed view of the servo tower 20 illustrating cutterassembly 200 and heater assembly 300 mounted on tip and cut carrier 100,and a registered multi-axis gripper 155 carrying needle 21 that ispositioned for receiving the suture strand within the suture receivingend thereof.

FIG. 2(b) is a detailed side view of the cutting assembly taken alongline 2'-2' of FIG. 2(a) showing the pulley assembly for moving tip andcut carrier assembly 100 of the instant invention.

FIG. 3(a) is a detailed view of the tensioner assembly 59 for increasingor decreasing suture strand tension as desired.

FIGS. 3(b)-3(g) illustrate the multi-axis needle gripper 155 and swagingand suture alignment dies shown in various stages of the sutureinsertion and needle swaging sequence.

FIG. 4 is an enlarged view of a gripper assembly having gripper armsshown in their closed (suture gripping) and open positions.

FIG. 5 is a detailed top view of the cutter assembly 200 for cuttingmaterial in the instant invention.

FIG. 6 is a detailed top view of the cutter assembly 200 shown in afully retracted position.

FIG. 7 is a detailed top view of the cutter assembly 200 shown in afully extended (cutting) position.

FIG. 8 is a detailed top view of the tipping assembly 300 for heating aportion of the suture material.

FIG. 9 is a top view swage dial assembly 101 having four multi-axisgripper stations.

FIG. 10(a) is cross-sectional view of the four station swage dialassembly 101 showing multi-axis gripper 155 in a retracted position.

FIG. 10(b) is cross-sectional view of the four station swage dialassembly 101 showing multi-axis gripper 155 in an extended position.

FIG. 11(a) is front face view of the multiaxis gripper 155 showing asurgical needle 21 in a relaxed engagement thereby, and additionallyshowing pin in a retracted position.

FIG. 11(b) is front face view of the multi-axis gripper 155 showing asurgical needle 21 in an engaged position therein.

FIG. 11(c) is a hidden view of the actuating mechanism used to releasethe grip of the needle on the multi-axis gripper.

FIG. 12(a) is cut away top view of the cam dial plate 110 showing camfollower 165a in a retracted position within cam track 182a.

FIG. 12(b) is cut away top view of the cam dial plate 110 showing camfollower 165a in an extended position within cam track 182a.

FIG. 13 is a cross-sectional view of the cam dial 125 mounted coaxialwith the swage dial 110 for cooperative rotational movement thereof, andshowing cam followers 165a,c in their retracted positions withinrespective cam tracks 182a,c.

FIG. 14(a) is a top view of the swage assembly 400 of the instantinvention.

FIG. 14(b) is a detailed view of the swage stop mechanism for swageassembly 400.

FIG. 15(a) is a detailed top view of the swage dies 420,430 of the swageassembly showing the recesses 434,435 formed in the swage die opening432 located therebetween.

FIG. 15(b) is an enlarged view of the swage die opening shown encircledin FIG. 15(a).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 is a block diagram generally illustrating the system 10 used toautomatically draw an indefinite length of suture material for cutting apredetermined length thereof, and to automatically insert the cut suturewithin a suture receiving end of a surgical needle for automatic swagingthereof. The entire process takes place at a swaging station whichcomprises an apparatus used to draw and cut an indefinite length strandof suture material to a uniform length and insert the tip thereof withinthe suture receiving end of a surgical needle prior to swaging asdescribed in copending patent application U.S. Ser. No. 08/181,595,entitled "R.S.O. Suture Cutting Station" assigned to the same assigneeof the present invention and incorporated by reference herein.

In the automatic needle threading and swaging process 10 shown in FIG.1, surgical needles are individually loaded from a precision conveyor orany suitable means, onto a multi-axis gripper located on a rotary swagedial as indicated as step 12 and described in detail in copending patentapplication U.S. Ser. No. 08/181,598, entitled "Needle ThreadingSwedging System" assigned to the same assignee of the present invention.The rotary swage dial is indexed so that the multi-axis gripperpositions the needle in a precisely oriented position between twoswaging dies of a swage assembly which is indicated as step 13 inFIG. 1. At the same time, an indefinite length of suture strand is drawnfrom a king spool along a single axis of a drawing tower and a tipthereof is stiffened and registered for insertion within the suturereceiving end of the needle, as shown as step 11 in FIG. 1. Next, atstep 14, the multi-axis gripper releases its grip on the needle placedbetween the opening formed by the swaging dies. At the same time thegripper assembly at the drawing tower inserts the tip of the suturestrand within the lower invertedly tapered alignment guide to positionthe tip within the suture receiving end of the needle, as shown as step16. Next, at step 17, the swage cylinder is activated to automaticallyswage the suture strand to the needle while a cutting assemblysimultaneously cuts the indefinite length of suture strand to apredetermined length. While retaining the armed needle, the multi-axisgripper is then retracted on the swage dial as shown as step 18.Finally, the armed needle is indexed to a pull-test station at step 19where minimum pull testing and/or destructive pull testing may beperformed. A detailed explanation of the apparatus used to carry outeach step will be explained in further detail hereinbelow.

The Drawing Tower

A payoff assembly for accomplishing the task of automatically drawing anindefinite length suture material is embodied as a drawing tower 20shown in FIG. 2(a). The drawing tower 20 comprises left side rail andright side rail 24 mounted on suitable mounting block 25 and defining adrawing bed for drawing an indefinite length of suture material along adrawing axis therebetween. Located parallel to the left and right siderails 22,24 and suitably connected thereto are respective left guide rod26 and right guide rod 28. The first gripper means or right gripper 32reciprocates up and down along right guide rod 28 while the secondgripper means or left gripper 30 reciprocates up and down the left guiderod 26. Each of the grippers 30,32 grip the suture material that is fedfrom a spool through pulley 35 located at the bottom of the drawingtower 20, and carries the material to the upper end of the tower. Theright gripper 32 is mounted on right gripper carrier 33 for verticalmovement along right guide rod 28, and the left gripper 30 is mounted onleft gripper carrier 31 for vertical movement along left guide rod 26 asshown in FIG. 2(a). FIG. 4 illustrates a gripper 32 (and 30) having agripper arm drive 61 that is pneumatically operated to drive pair ofretractable gripper arms 65a, 65b toward each other to a suture grippingposition, or, away from each other to an open position. Each retractablegripper arm is provided with a resilient, non-metallic pad 66a, 66b forgripping the suture material 55 at a free end thereof when actuated tothe gripping position. To release the grip of the suture, gripper arms65a,65b are retracted approximately 180 degrees apart in the directionindicated by the arrows of FIG. 4 to the open position. When in the openposition the gripper arms 65a', 65b' do not interfere with the motion ofthe other vertically moving gripper as it reciprocates along therespective left or right rod, nor will it interfere with the cutterassembly 200 that cuts the strand to a predetermined length as will beexplained below. The retractable nature of the grippers and of thecutting assembly enables single drawing axis operation.

As mentioned above, each gripper carrier and gripper thereof is designedto advance vertically along the respective left and right rods. As shownin FIG. 2(a), the right gripper 32 and gripper carrier 33 is driven byright servo motor 38 which is mounted to the right side rail 24 by rightmotor mounting bracket 39. Similarly, the left gripper 30 and grippercarrier 31 is driven by left servo motor 36 which is mounted to the leftside rail 22 by left motor mounting bracket 37. In the preferredembodiment, both left and right servo motors are interfaced with andcontrolled by a control system computer, indicated generally as numeral80 in FIG. 2(a), and as explained in further detail in copending patentapplication U.S. Ser. No. 08/181,607, entitled "Control System" assignedto the same assignee of the present invention. As shown in FIG. 2(a),right servo motor 38 drives timing belt 43 which consequently enablesvertical positioning of right gripper carrier 33 along right rod 28,while the left servo motor 36 drives timing belt 41 which consequentlyenables vertical positioning of left gripper carrier 31 along left rod26. As FIG. 4 illustrates, timing belt 43 is clamped to its respectivegripper carrier 33 by a timing belt clamp 68 located on the back of thegripper carrier. A similar timing belt clamp (not shown) is provided ongripper carrier 31 for clamping timing belt 41 to enable verticalmovement of gripper 30. FIG. 2(a) shows timing belt 41 engaging upperleft pulley 45 and lower left pulley 46 as well as idler pulleys 47,48which are part of tensioner block 44 that adjusts the tension of thetiming belt 41 and consequently of left gripper carrier 31. Likewise,FIG. 2(a) shows timing belt 43 engaging upper right pulley 51 and lowerleft pulley 52 as well as idler pulleys 53,54 which are part oftensioner block 45 that adjusts the tension of the timing belt 43 andconsequently of right gripper carrier 33.

FIG. 2(a) additionally illustrates the tip and cut carrier 100positioned along shafts 104 and 105 which are located parallel torespective left and right rods 26,28. Tip and cut carrier 100 providesthe support for tipping assembly 300 that applies heat to a specificlocation of the suture material, and also provides support for thecutter assembly 200 that cuts the suture material. In the preferredembodiment, vertical movement of the tip and cut carrier 100 isaccomplished by cranking handwheel 108 shown in FIG. 2(b). Otherembodiments may implement a computer controlled servo motor tovertically register the tip and cut carrier 100 prior to cutting thematerial.

As illustrated in FIG. 2(b), cranking handwheel 108 actuates a gearbox113 that rotates chain drive sprocket 114. The gearbox 113 is mounted ona gearbox mounting bracket 122 which, in turn, is mounted to framemember 99. A cable chain 115 is engaged with chain drive sprocket 114 toactuate movement of the tip and cut carrier 100 as shown in FIG. 2(b).The cable chain 115 also engages chain idler sprockets 118 and 119 whichare rotatably mounted to upper tensioner pulley bracket 121 and lowertensioner pulley bracket 123, respectively. The vertical positioning oftensioner pulley brackets 121,123 may be adjusted to vary the slack incable chain 115. Cable chain 115 also engages chain idler sprockets 127and 129 which are suitably mounted on left side rail 22. As shown inFIG. 2(a), the back 111 of tip and cut carrier 100 is clamped to cablechain 115.

Both the stroke of the grippers 30,32 and the positioning of the tip andcut carrier 100 along drawing tower 20 dictates the length of thematerial that will be cut. For instance, as shown in FIG. 2(a),proximity sensors 73,74, and 75 are positioned vertically at differentheights along the drawing tower 20 to enable predetermination of thelength of suture material to be cut. Specifically, the locations of theproximity sensors 73,74, and 75 sense the positioning of the tip and cutcarrier 100 as controlled by handcrank 108 in order to notify thecontrol system 80 to change the reciprocating travel of grippers 30,32.Also as shown in FIG. 2(a), proximity sensor 70 is mounted at a positionalong the right side rail 24 to verify that right gripper 32 has reacheda desired position at the upper end of the tower 20 and notify thecontrol system 80 and servomotor 38 accordingly. Likewise, a proximitysensor (not shown) is mounted at the desired height along the left siderail 22 to verify that left gripper 30 has reached its desired positionat the upper end of the drawing tower 20.

Preparing a predetermined length of (suture) material for cutting andswaging is accomplished as follows:

FIG. 2(a) shows suture material 55 being drawn by first gripper means orright gripper 32 from a king spool 50. In an alternative embodiment, thespool may be motor driven in which case a dancer assembly 59 may beprovided to control the tension of the material as it is being fed. Asshown in FIGS. 2(a) and 3(b), the lead gripper (gripper 32) grips thesuture material 55 in the above-described manner just slightly below itstipped end 58.

To feed the indefinite length suture material up the length of thedrawing tower, the suture material 55 is first manually threaded througheyelet 56 and through optional knot detector 57 which senses any suddenchange in the thickness of the suture material. Detection of a knot insuture material 55 will trigger the control system 80 to discard the cutstrand of material at a subsequent operation. Additionally, the suturematerial may be threaded within a tensioning (or dancer) assembly 59which comprises a plurality of vertically spaced apart cones 23 each ofwhich may be positioned laterally to increase or decrease the tension ofthe suture strand 55 as shown generally in FIG. 3(a).

The suture material 55 is then advanced over pulleys 35a and 35b andfurther around pulley 112 which is mounted on the lower portion of tipand cut carrier 100 that is illustrated near the center of the tower asshown in FIG. 2(a). Note that the lower threading pulley 35b, guidepulley 112, left gripper 30 and right gripper 32 are vertically alignedso that the cutter assembly 200 will always cut horizontally across thestrand of material as will be discussed in detail below.

Under the control of the control system computer 80, the right servomotor 38 is enabled to drive the lead (right) gripper vertically alongright rod 28 to register the tip of the indefinite length suture strand55 for positioning within the suture receiving opening 29 of a preciselyoriented surgical needle shown engaged by the multi-axis gripper 155 atthe swaging assembly 400 located at the top of the drawing tower 20 asshown in FIG. 3(b). To accomplish this, the lead gripper servomotoradvances the lead gripper for a long stroke distance, which may rangefrom 12 inches to 36 inches depending upon the length of said suturestrand desired, but is 16.1 inches in the preferred embodiment. The longstroke moves gripper 32 from a home position above the tip and cutcarrier 100 and below the cutter assembly 200, to the position slightlybelow swaging assembly 400 as shown in FIG. 2(a) .

Simultaneous with the positioning of the lead gripper 32 during the longstroke, the other servomotor, for e.g., servomotor 36, positions thealternate gripper, for e.g., left gripper 30, along left rod 26 at thehome position preferably above the tip and cut carrier 100 and below theposition of the cutter assembly 200 as shown in FIG. 2(a). It isunderstood that the top or right gripper is gripping the material 55 atall times during the long stroke, while the bottom or left gripper is inits open position and not gripping. The process of advancing suturematerial 55 by alternating grippers at each cycle eliminates the recycleor return time for retaining the gripper to the original position. Thismakes faster machine speeds and hence, higher production rates possible.

To insert the tipped end 58 of the suture material within the suturereceiving opening 29 of surgical needle 21, the lead gripper 32 againadvances the suture material 55 for a short stroke distance of about 1.9inches, so that the tipped end 58 will advance precisely within thesuture receiving opening 29 of needle 21 for a swaging operation to takeplace at the swaging assembly 400.

As the tipped end 58 of the suture material is advanced during the shortstroke distance, a tipped portion 78 of the material 55 that has beenheated by tipping assembly 300, (explained hereinbelow), advances to aposition slightly above the location of the left gripper 30 and adjacentthe cutter assembly 200. Then, as the automatic swaging of the tippedend 58 to the surgical needle occurs at swaging assembly 400, the leftgripper 30 (lower gripper) is actuated to grip the material 55 in thetipped portion 78, i.e., the portion of the suture material heated bytipping assembly 300 as shown in FIG. 2(a), and the cutter assembly 200is actuated to cut the tipped portion 78 of the suture material 55 sothat the left gripper 30 is now gripping an indefinite length suturestrand 55 having a tipped end 58. Simultaneous with the engagement ofleft or bottom gripper 30, the top or right gripper 32 is actuated torelease its grip on the definite length suture material.

Heater Assembly

As mentioned above, immediately after advancing the long stroke distanceand prior to advancing the short-stroke distance, the lead gripper istemporarily halted so that a portion of the suture material 55 may beheated (tipped). Heating of the suture under tension and the subsequentcooling thereof will stiffen the material and aid in the positioning andsubsequent swaging of the tip of the material within the confines of thesurgical needle. The operation of the tipping assembly 300 mounted ontip and cut carrier 100 will now be explained as follows:

As shown in FIG. 8, the tipping assembly 300 is essentially an ovencomprising a heat exchanger unit 305 that heats the air in the heatercavity 306. When a pulse of incoming air is provided to the heatexchanger input 307, the heated air is displaced and it provides a pulseof heated air to a vertical cylindrical cavity 310 as shown in FIG.2(a). As shown in FIG. 8 the heated air is forced through horizontalorifice 315 for a predetermined duration so that the length of suturematerial 55 suspended in tension through vertical cavity 310 will beheated. The control system computer 80 controls the duration of the heatpulse so that the material is adequately heated and will have sufficienttime to cool before the cutting operation. Preferably, the tippingassembly 300 is located at a position that is located slightly below thebottom or left gripper. As mentioned above, this is required so thatwhen the suture material 55 is advanced the short stroke distance, thetipped portion 78 of material 55 will advance a corresponding distanceso that it may be cut by cutter assembly 200. This ensures that thebottom gripper, e.g., left gripper 30, will grip the material having anew tipped end 58 for the next suture draw/insert cycle.

It should be understood that various other "tipping" technologies willwork depending upon the type of suture material that is being processed.For instance, when VICRYL® and VICRYL®-like suture materials are used,tensioning of the strand, in addition to hot air application to a strandwill enable the surface thereof to be melt and recast to form astiffened tip. The application of tension in addition to a heated,grooved, die for forming the tip diameter of VICRYL® suture materialsmay also be used; however, the use of a die to form the tip diameter,requires closer control of the strand location to ensure that a tip getsinto the die groove for every cycle. For wax-impregnated suturematerials like silk, the application of tension only at predeterminedlocations, will form a stiffened portion of the suture strand at thoselocations. Another tipping method for use with braided suture materials,involves applying and penetrating the braid with a dilute resin materialsuch as General Electric's VITEL® having a high solvent content, andquick drying the applied portions with hot air while maintaining tensionof the suture strand materials to form a stiffened tip thereof.

Cutter Assembly

FIGS. 5-7 illustrate in detail the cutter assembly 200 which is suitablymounted to the tip and cut carrier 100 as shown in FIG. 2(a). As shownin FIG. 6, the cutter assembly comprises overcenter linkage 214 having alink arm 217 pivotally connected at one end thereof. A pivotal locatorarm 220 is fixedly connected to link arm 217 at a second end thereof andis illustrated in FIG. 6 as substantially transverse thereto. The otherend of locator arm 220 is pivotally connected to a stationary guidemechanism 226. Note, that all pivotal linkages described herein aresimple pin linkages, the actuation of which creates the dwell moment forcutting the suture strand and obviates the need for complicated cam,slots, and sliding mechanisms.

As shown in FIG. 6, the stationary guide 226 is located in a planeperpendicular to the drawing axis of the suspended strand of material55, and is located a distance from the strand approximately equivalentto the length of locator arm 220. In addition, overcenter linkage 214,locator arm 220, and cutting blade 230 all lie in planes perpendicularto the drawing axis of the strand of material 55.

A retractable ball slide 228 is mounted on the stationary guide 226 andcoupled to overcenter linkage 214 for moving the overcenter linkage 214and blade 230 along the stationary guide 226 in the direction indicatedby arrow "A" in FIG. 5 from a cutting position to a retracted positionshown in FIG. 6. As the ball slide 228 moves overcenter linkage 214 to aretracted position, the locator arm 220 is pivoted away from the strand55 and the blade 230 is retracted. Thus, when the cutter assembly 200 isin the retracted position prior to cutting of the strand and immediatelythereafter, the blade 230 and locator arm 220 do not interfere with thereciprocating motion of the grippers 30,32 along the drawing tower 20,nor do they come in contact with the suspended strand 55. In thepreferred embodiment, pneumatic air cylinder 222 enables reciprocatingmovement of the ball slide 228 along stationary guide 226 as shown inFIG. 5.

When cutting the strand of material 55, the retractable ball slide 228reciprocates in the direction toward the strand 55 indicated by arrow"B" in FIG. 6 to bring the overcenter linkage 214, cutting blade 230 andlocator arm 220 to the cutting position shown in FIG. 7. As theovercenter linkage 214 moves to the cutting position, the link arm 217translates the movement of the ball slide 228 into pivotal movement ofthe locator arm 220. Locator arm 220 is provided with a V-shaped supportnotch 223 which functions to engage and position the strand of material55 to be cut as the arm is pivoted into the cutting position. TheV-shaped notch also functions to support the strand on two sides of thestrand 55 while it is being horizontally cut on a third side. Thisenables clean, broom-free cuts especially of multi-filament suturematerial, which has a tendency to form a broom end when the strand isunder tension and is cut by scissors, or, when the multifilament strandis sliced and otherwise, not properly supported.

The cutting blade 230 of cutter assembly 200 is fixedly mounted toreciprocating ball slide 228 at a slight angle relative thereto and in aplane parallel with that of the locator arm 220. In the preferredembodiment, a single action by the pneumatic air cylinder 222 willenable movement of the reciprocating ball slide 228 along stationaryguide 226. This consequently enables pivoting of locator arm 220 fromits retracted position (FIG. 6), so that V-shaped notch 223 supports thestrand 55 at two sides thereof while a third side of the strand bearsupon the cutting edge of blade 230 as the blade moves towards thesupported strand 55 traversing the drawing axis thereof. Thus, thestrand 55 is cut in a dwell moment of the locator arm after the locatorarm 220 has pivoted in the direction toward the blade 230 to the cuttingposition shown in FIG. 7. The blade 230 slices the strand of materialwhile it is held stationary by locator arm 220 by virtue of the angledorientation of the blade with respect to the axis of reciprocationillustrated in FIGS. 6 and 7. In the preferred embodiment, the sliceratio is 1:1, with the blade 230 angled at approximately 45 degreesrelative to the axis of reciprocation, so that the strand 55 is cut anamount equivalent to the distance the blade 230 traverses the drawingaxis.

Swage Dial/Multi-axis Gripper

As illustrated in FIG. 9, the needle and suture swaging station includesa rotatable swage dial assembly 101 having four separate multi-axisgripper stations 82a,b,c,d where simultaneous operations are performed.The swage dial assembly 101 includes a swage dial 110 that is mounted toa rotatable central hub 99 which rotates under the control of a controlsystem computer 80. In the preferred embodiment, a reciprocatingcarriage is provided at each station of the swage dial assembly 101. Forinstance, as shown in FIG. 9, swage dial station 82a includesreciprocating carriage 150a, while station 82b includes reciprocatingcarriage 150b, station 82c includes reciprocating carriage 150c, andstation 82d includes reciprocating carriage 150d. Mounted to eachreciprocating carriage 150a,b,c,d for retractable movement therewith, isa multi-axis gripper 155, one of which is shown connected toreciprocating carriage 150c in FIG. 9. The multi-axis gripper 155includes pins 142,146, and 148 as shown in FIG. 11(a) that retain thesurgical needle 21 in a fixed position. When the multi-axis gripper 155is in the retracted position shown in FIG. 10(a), the needle 21 is beingindexed to a different station as the swage dial rotates; when thegripper 155 is in the extended position as shown in FIG. 10(b), theneedle is in one of the active stations, such as the station where it isregistered for automatic swaging. A description of the preferredembodiment of the multi-axis gripper 155 follows hereinbelow.

As shown in FIG. 11(a), pins 142, 146, and 148 of the multi-axis gripper155 extend perpendicularly from the gripper pin assembly 152 of thegripper to engage the arcuate portion 27 of needle 21, and to retain theneedle in an oriented position. FIG. 11(b) illustrates pin 142 locatedalong the outer arcuate portion of the needle 21, while pin 146 supportsthe pin at the inner arcuate portion 27 of the needle 21. The barrelportion of the needle 21 fits adjacent protruding stop 148 located onthe gripper pin assembly 152 of the gripper 155 as shown in FIG. 11(b).The location of the stop 148 may be adjusted to accommodate theengagement of different size surgical needles. In the preferredembodiment, the gripper pin assembly 152 is replaceable with othergripper pin assemblies having the stop 148 positioned to accommodatedifferent sized surgical needles. Note that another pin, such as pin 144shown in FIGS. 11(a) and 11(b) may be provided for further support ofthe needle when in a relaxed position upon the multi-axis gripper.

The three pin engagement configuration shown in FIG. 11(b) ensures thatthe needle 21 will not be displaced when the swage plate 110 isrotating, or, when the multi-axis gripper 155 is being retracted orextended. In the preferred embodiment, pin 142 is spring loaded and isretractable within guide 147 to release its grip of needle 21 prior toswaging thereof. FIG. 11(c) illustrates plunger 149 connected toactuating lever 143 having a pin 145 mounted thereon and adjacent oneleg of torsion spring 141. To retract pin 142 within guide 147 needle,the plunger 149 is depressed by a suitable lever or push rod to rotatelever 143 causing pin 145 to move torsion spring 141 into engagementwith pin 142 to retract the same to the non-engaging and relaxedposition shown in FIG. 11(a). When engaging the surgical needle 21 afterswaging, pin 142 is biased back into the needle engaging position asshown in FIG. 11(b). Note in FIG. 11(a) that the barrel portion ofneedle 21 extends below the gripper pin assembly 152 of the multi-axisgripper 155. This enables pick up of the needle at a first station andplacement of the suture receiving end 29 of the needle within the swagedies of the swaging assembly as will be explained below.

The process for extending each multi-axis gripper 155 for sutureinsertion will now be explained. As shown in FIGS. 10(a) and 10(b), eachcam follower 165a(b,c,d) is mounted to a cam slide 164 at one end of thereciprocating carriage 150a(b,c,d), and the multiaxis gripper 155 isconnected to the cam slide 164 at the other end. Cam slide 164 isslidable within stationary guides 166,167 and is adapted for reciprocalmovement when the cam follower 165 is actuated. In the preferredembodiment shown in FIG. 12(a), cam follower 165 is a roller that fitswithin cam tracks of a rotatable cam dial assembly 120. Cam dialassembly 120 is shown in FIG. 12(a) as comprising a cam dial plate 125having four cam tracks 182a,b,c, and 182d which correspond to a swagedial stations 82a,b,c, and 82d, respectively. Each cam follower 165 ispositioned within each respective cam track at each station for movementtherein. For instance, as shown in FIG. 13, cam follower 165a ispositioned within cam track 182a and cam follower 165c is positionedwithin cam track 182c. Also in FIG. 13, cam dial 125 is positioned aboveswage dial 110 and mounted coaxial therewith. The cam dial 125 isrotatable about a central shaft 199 and controlled by a separate rotaryindexing transmission (not shown) so that it may rotate separately fromthe swage dial plate 110. FIG. 12(a) shows cam follower 165a in a firstretracted position within the cam track 182a. When in this position,reciprocating carriage and consequently multi-axis gripper 155 are intheir retracted position as shown in FIG. 10(a) discussed above. Toextend the multi-axis gripper 155 in place at its respective station,the cam dial plate 125 is rotated in the clockwise direction indicatedby the arrow in FIG. 12(a) for approximately 45-55 degrees relative toswage dial plate 110, forcing cam follower 165a in its cam track 182a tomove toward the periphery of the dial as shown in FIG. 12(b).Consequently, the cam slide 164, reciprocating carriage 150a, and themulti-axis gripper 155 move to the extended position as shown in FIG.10(b) and discussed above. To move back to its retracted position, thecam dial 125 is rotated in the counter clockwise direction relative tothe swage dial plate 110 for approximately 45-55 degrees, forcing camfollower 165a in its respective cam track 182a to move to its retractedposition (FIG. 10(a)).

It should be understood that when cam dial plate 125 rotates withrespect to swage dial plate 110, each multi-axis gripper 155 is eitherextended or retracted by its respective cam track. Thus, the system isdesigned so that all processes performed at each station occursimultaneously and for approximately the same duration of time when themulti-axis grippers are in their extended position, for e.g., for needlepickup, for needle swaging, or, for needle pull-testing. The timing ofthe system is operated under a control system, the description of whichcan be found in the above-mentioned copending patent application U.S.Ser. No. 08/181,607, entitled "Control System ".

When the multi-axis gripper 155 is retracted, the needle engaged therebymay then be indexed to a different station for further processing. Toindex the needle to another station, both swage dial plate 110 and camdial plate 125 are rotated together for approximately 90 degrees toposition the multi-axis gripper at the next station. For example, whenthe cam dial plate 125 and the swage dial plate 110 are simultaneouslyrotated 90 degrees counterclockwise in FIG. 13, the gripper 155 that hadreceived the needle at station 82a is now indexed to the positioncorresponding to station 82b for swaging a suture thereto. After swagedial plate 110 stops rotating, cam dial plate 125 is rotated anadditional amount to cam the four multi-axis grippers to the extendedposition. Similarly, after swaging, the cam dial plate 125 and the swagedial plate 110 are simultaneously rotated counterclockwise so that thearmed needle at station 82b is conveyed to the position corresponding tostation 82c for pull-testing thereof. The operations performedconcurrently at each station about the swage dial increases throughputto provide an output of pull-tested armed surgical needles at a rate ofapproximately 60 per minute in the preferred embodiment.

Swaging Assembly

The swaging operation taking place at the swaging station will now bedescribed. FIGS. 3(b)-3(g) illustrate the multi-axis needle gripper 155and swaging and suture alignment dies shown in various stages of thesuture insertion and needle swaging sequence. This sequence, and theinteraction of the dies in relation to each other, the needle, and theinsertion of the suture, accomplish the insert and swage function withminimal parts and simple motions.

After conveying the needle to swaging assembly 400, the multi-axisgripper 155 is radially extended from the swage dial in the mannerdescribed above to position the suture receiving end 29 of needle 21between the funnel shaped die opening formed at the ends of two swagedies 420,430 as shown in FIG. 3(b) and the partial perspective view ofFIG. 3(c). As will be explained in detail below, swage die 420 is fixedin position and swage die 430 is moved laterally toward the fixed swagedie 420, as indicated by the arrow, to accomplish swaging of the suturereceiving end of a needle placed therebetween. A funnel shaped dieopening 432 having an exit diameter slightly larger than the diameter ofthe suture receiving end 29 of the needle is formed when the two swagedies 420,430 are positioned adjacent each other as shown in FIGS. 3(e)through 3(g). In the preferred embodiment shown in FIGS. 15(a) and15(b), the ends of each of the swage dies 420,430 are provided withrecesses 434,435, respectively, so that the metal deformation thatoccurs as a result of the swaging of the needle 21, does not result inmetal flash or spurs at the suture receiving end 29 of the needle. Notethat different sets of swage dies may be provided, depending upon thesize (diameters) of the needles and sutures to be swaged.

To precisely position the suture receiving end 29 of needle 21 betweenthe die opening formed at the ends of the two swaging dies 420,430, themovable swage die 430 is temporarily moved apart. In the illustration ofthe swaging assembly 400 shown in FIG. 14(a), swage die 430 is movedapart from the fixed swage die 420 by actuating air cylinder 445 whichprovides a force upon cylinder rod 443 to enable swage die operatinglever 447 to pivot about screw 449 and pull moveable swage die 430 apredetermined distance away from the fixed swage die 420. In thepreferred embodiment, lever 447 is biased by spring 431 so that themovable swage die 430 will return toward the fixed swage die by thespring restoring force when the pressure provided by the air cylinder445 is terminated.

FIG. 3(d) shows die 420 in its fixed position, and moveable die 430 inits spaced apart position prior to receiving the surgical needle 21presented by multi-axis gripper 155. Suture alignment die 425,containing suture guide funnel half 425b, is positioned under die 420,and free to slide laterally within limits. Alignment die 425 has a tang425a that protrudes into cavity 420a formed within swage die 420.Compression spring 420c bears against the back wall of cavity 420a andtang 425a such that funnel die 425 slides forward until it isconstrained by cavity wall 420b. In this position, it is forward of thecenter axis defined by the suture receiving end of the needle, andserves as a shelf 425c that helps assure suture receiving end 29 ofneedle 21 is in position for swaging. In this stage of the cycle, theparts are not positioned for suture insertion, and suture clamp 65agripping suture 55 and stiffened end 58, are in dwell. Suture alignmentdie 426, containing funnel half 427, is fastened to swage die 430 bysuitable fastening means, described in detail below, and travels with itto the open position shown.

While the swage dies 420,430 are apart, the multi-axis gripper 155 isextended to position the suture receiving end of needle 21 within theopening 432 as shown in FIG. 3(d) and FIG. 14(a). After positioning thesuture receiving end 29 of needle 21 at the swage die opening 432, theswage die 430, and suture alignment die 426, are moved toward needle 21with the resilient spring force present in spring 431 (FIG. 14(a)) thatis sufficient to enable the die 430 to grip and locate the suturereceiving end 29 precisely against fixed swage die 420 without deformingthe cavity of the suture receiving opening 29 formed therein.Concurrently, needle retaining pin 142 in multi-axis gripper 155 israised by downward external force on plunger 149, as described above,thereby releasing the needle so that its position is determined by thegrip of swaging dies 420 and 430. The motion of dies 426 and 430 causethe face 426a of suture alignment die 426 to come in contact with thecorresponding face 425c of suture alignment die 425. The resilient forcecausing this motion is forceful enough to compress spring 420c, and movefunnel die 425 to the left, such that tang 425a is no longer in contactwith cavity wall 425b. Dimensioning of dies 430 and 426 is such thatthis motion results in the formation of two funnel halves 425b and 427defining a smooth conical shape that is coaxial with the suturereceiving end 29 of needle 21. FIG. 3(e) shows the suture receiving end29 being gripped by the swage dies 420,430 prior to suture insertion.Note that the exit diameter of the conically shaped funnel guide formedof funnel halves 425b and 427 is preferably equal to or greater than thediameter of the suture tipped end 58 and smaller than the diameter ofthe suture receiving end 29 of the needle 21, as shown in FIG. 3(f), sothat the tipped end 58 of the suture strand may be easily insertedtherein.

FIG. 3(f) shows suture gripper 65a moved vertically to the insertionposition, which causes stiffened suture end 58 to enter funnel 425b and427, and be guided into the suture receiving cavity 29 of needle 21axially aligned therewith. Once the strand is inserted into the suturereceiving end 29 of the needle (step 16) as discussed above, theautomatic swaging of the suture receiving cavity occurs. In thepreferred embodiment of the swaging assembly 400 shown in FIG. 14(a), apneumatic air cylinder supplies air pressure to swage air cylinder 450which actuates cylinder rod 433 that bears on lever 447 to thrustmovable swage die 430 toward the fixed swage die to accomplish theswaging of the suture receiving end of the needle placed therebetween.Air pressure is supplied to the swage cylinder 450 via ports 451,452under the control of the control system computer 80.

FIG. 3(g) shows the completed swage stroke. The swage die 430 has beendriven to a fixed stop by the swage cylinder, which exerted sufficientforce to deform the suture receiving end 29 of needle 21. As deformationtakes place, suture alignment die 426 further displaces funnel die 425,causing additional compression of spring 420c. In the preferredembodiment, the moveable swage die 430 comes to an automatic stop by aswage stop mechanism herein described.

As shown in FIG. 14(b), movable swage die 430 and suture alignment die426 are mechanically held coincident to each other by shouldered post471, the smaller diameter of which is a light press fit into the matinghole in die 430. Cap screw 474 with washer 476 retain the post in die430. The larger diameter of post 471, below die 430, extends through alight press fit hole in funnel die 426 so that the right hand swage andfunnel dies are linked to move together laterally during the swagingcycle. The lower portion of shouldered post 471 extends through funneldie 426 into groove 479, which is cross milled into swage assembly frame480. When the swage stroke is performed, the swage cylinder drives thisdie assembly to the left until it is positively stopped by the lowerportion of post 471 striking wall 481 of groove 479. This stalls aircylinder 450, so that the stroke of the moveable swage die assemblyshown is always the same for repeating cycles of the machines.

In an alternative embodiment, both swage dies 420,430 may be movabletowards each other to accomplish swaging. Furthermore, an adjustableswage stop mechanism for changing the swage stroke distance of one ofthe movable dies may be provided to further control the swaging pressureapplied to the suture receiving opening.

As shown in the top view of FIG. 14(a), a needle fence assembly 428 isprovided to ensure that the needle 21 does not tip or become misalignedwhen the needle is being swaged. The needle fence assembly 428 comprisesa needle fence plate 429 whose distance from the swage die opening 432is adjustable depending upon the size of the surgical needle to beswaged.

In the preferred embodiment, the degree of swage compression imparted onthe needle, and resulting strength of grip by the needle on the suture,is adjusted by precise positioning of the fixed die 420. As shown inFIG. 14(a), servomotor 460 drives pulley 462 via timing belt 461 whichrotates the swage adjust screw 475. The pitch of the swage adjust screw475 is selected to move sliding wedge 465 a small distance. The swagedie 420 has a complementary ramp angle 423 at the opposite end whichbears on the wedge 465 to retract or advance the position of the swagedie 420 a precise distance proportional to the movement of the slidingwedge. Thus, the rotation of the swage adjust screw 475 and motion ofthe sliding wedge 465, results in transverse movement of the swage die420 to thereby finely adjust its fixed position. For example, when alarger suture is to be swaged to a needle, the position of the fixedswage die 420 may be moved further away from the suture drawing axis sothat less swaging pressure is applied to the needle when the movableswage die 430 is thrust towards the fixed die to a stop. In thepreferred embodiment shown in FIG. 14(a), the control system computer 80will send the appropriate signals to automatically direct the servomotor460 to adjust the position of the swage adjust screw 475, and hence, theposition of the fixed die 420, in accordance with the pull-out testvalues of the needle-suture bond as measured downstream of the swagingstation by an automatic pull-test system as explained in further detailin copending patent application U.S. Ser. No. 08/181,601, entitled"Needle and Suture Automatic Pull Test System" assigned to the sameassignee of the present invention. Specifically, appropriate signals maybe sent to automatically direct the servomotor 460 to adjust therotational position of the swage adjust screw 475 in accordance withstored statistical results of the pull-testing occurring at thepull-test station. Automatic pull-testing of the armed needle isdesirable to ensure that the upstream swaging dies are optimallypositioned to avoid over-swaging the needle-suture bond and hence,preventing the likelihood of clip-off, and, to avoid under-swaging theneedle-suture bond to prevent the chance of pull-out.

Immediately after the short stroke of the right or top gripper 32, theleft gripper 30 secures the suture strand, and the suture material 55 iscut by the cutting assembly 200 in the manner described above and asindicated in step 17 in FIG. 1. As shown in FIG. 2(a), the cutterassembly 200 is positioned slightly above the left gripper 30 so thatthe indefinite length suture strand 55 will be gripped when the swagedstrand is cut. Thus, the left gripper 30 is now gripping the suturematerial 55 with a tipped end 58 and it now becomes the lead gripper.

In the preferred embodiment shown in FIG. 2(a), a vacuum air flow isenergized to pull the strand of material 55 toward the nylon screen 251to more precisely locate the suture strand in the target zone of thecutter. After cutting of the indefinite length suture material 55, thetail end 58 of the length of suture material that had been swaged to thesurgical needle is sucked into a large vacuum pipe 275, that isconnected to a vacuum assembly (not shown) by vacuum hose 280 as shownin FIG. 2(a). The vacuum created in vacuum pipe 275 exerts a mildtension in the strand of material to keep the tail end from entanglementor coming into contact with the machinery. However, it is mild enough toallow the strand to be pulled out of the pipe 275 as the armed needleand suture are indexed for further downstream processes.

After swaging of the needle, the movable die 430 is again retracted byair cylinder 445 and the pin 142 of the multi-axis gripper 155 isactuated to engage the armed needle as described above. Subsequently,the multi-axis gripper 155 is retracted (step 18) to its position alongthe swage dial 101 for subsequent indexing to the next station, fore.g., pull-test station, or, for further processing (step 19).

The cycle continues at the swaging station with the left gripperbecoming the top gripper and vertically drawing the suture material 55along the height of the drawing tower 20 to position the next strand tobe cut for insertion within the surgical needle. As mentioned above, theprocess of advancing suture material 55 by alternating grippers at eachcycle eliminates the recycle or return time for retaining the gripper tothe original position.

While the invention has been particularly shown and described withrespect to the preferred embodiments thereof, it will be understood bythose skilled in the art that the foregoing and other changes in formand details may be made therein without departing from the spirit andscope of the invention, which should be limited only by the scope of theappended claims.

What is claimed:
 1. A needle and suture threading machine forautomatically threading and swaging a surgical needle having a suturereceiving opening formed therein, said machine comprising;(a) a leadgripping means for gripping a suture strand from an indefinite lengthsupply of suture material, said lead gripping means being reciprocallydisposed along a common suture axis from a first position to a secondposition, said second position defining an insertion zone; (b) means forcleanly cutting said suture strand at said first position to create asuture strand of definite length gripped by said at lead gripping means,and a suture of indefinite length; (c) indexing means for positioningsaid needle between first and second swaging dies with said suturereceiving opening aligned with said suture axis; (d) a funnel guidemeans positioned at said second position between a free end of saiddefinite length suture strand and said suture receiving opening of saidneedle; (e) means for advancing said lead gripping means along saidsuture axis, from said first position to said second position, and fordirecting said free end to the suture strand through said funnel guidemeans and into the suture receiving opening formed in said needle; and(f) swaging means for advancing at least one of said first and secondswaging dies toward the other to swage said needle about the suturestrand of definite length and form a needle suture assembly.
 2. Theneedle and suture threading and swaging machine according to claim 1,wherein said first swaging die is fixed in position and has an endthereof defining a portion of a swage die opening, and said secondswaging die is movable and has an end thereof defining another portionof said swage die opening, wherein said second swaging die is positionednext to said first swaging die to form said swage die opening forreceiving said needle.
 3. The needle and suture threading and swagingmachine according to claim 2 wherein said swaging machine furtherincludes means for moving said second swaging die laterally away fromsaid first fixed swaging die prior to positioning said needle withinsaid swage die opening.
 4. The needle and suture threading and swagingmachine according to claim 3, wherein said moving means further movessaid second swaging die toward said first swaging die to grip saidneedle placed therebetween.
 5. The needle and suture threading andswaging machine according to claim 4 wherein said moving means includesspring biasing means to provide a force sufficient to move said secondswaging die toward said first swaging die without deforming said suturereceiving opening of said needle positioned at said swage die opening.6. The needle and suture threading and swaging machine according toclaim 5, wherein said moving means includes an air cylinder forsupplying adequate force to move said second swaging die toward saidfirst swaging die to accomplish swaging of said needle grippedtherebetween.
 7. The needle and suture threading and swaging machineaccording to claim 6, wherein said second swaging die is moved towardssaid first swaging die for a swaging stroke of a predetermined distanceto accomplish said swaging.
 8. The needle and suture threading andswaging machine according to claim 7, wherein said moving means includesstop means for terminating the motion of said second swaging die duringsaid swaging stroke.
 9. The needle and suture threading and swagingmachine according to claim 3, wherein said swaging means includes fencemeans for maintaining the position of said needle within said swage dieopening during the swaging thereof.
 10. The needle and suture threadingand swaging machine according to claim 3, wherein said advancing meansfor advancing said at least one gripping means is a servomotor operableunder the control of a control system computer means.
 11. The needle andsuture threading and swaging machine according to claim 10, wherein saidswaging means further includes means for adjusting the position of saidfirst fixed swaging die to change the amount of swage deformationoccurring to said suture receiving opening during swaging thereof. 12.The needle and suture threading and swaging machine according to claim11, wherein said first fixed swaging die includes a wedge followerlocated at one end thereof, said means for adjusting the position ofsaid first fixed swaging die including a wedge assembly positioned tomove transverse to said wedge follower to laterally move said wedgefollower and said first fixed swaging die in accordance with transversemovement of said wedge assembly.
 13. The needle and suture threading andswaging machine according to claim 12, wherein said transverse movementof said wedge assembly is controllable by a servomotor means forrotating a swage adjust screw of a predetermined pitch, said rotation ofsaid swage adjust screw being translated into linear motion of saidwedge assembly.
 14. The needle and suture threading and swaging machineaccording to claim 13 wherein said control system computer meansdetermines and controls the optimum positioning of said first fixedswaging die to avoid over-swaging and underswaging said needle.
 15. Theneedle and suture threading and swaging machine according to claim 14wherein said control system computer means determines and maintains theoptimum position of said first fixed swaging die in accordance withpull-out force values of said needle-suture assembly as measureddownstream of said needle and suture threading machine.
 16. The needleand suture threading and swaging machine according to claim 2, whereinsaid indexing means includes means for gripping said needle in anengaged state or releasing said needle.
 17. The needle and suturethreading and swaging machine according to claim 16, wherein said needlegripping means is movable between a first retracted position prior topositioning and surgical needle within said swage die opening, and asecond extended position for positioning said needle within said swagedie opening.
 18. The needle and suture threading and swaging machineaccording to claim 17 wherein said needle gripping means includes aplurality of pin means for engaging said surgical needle atpredetermined locations, one of said plurality of pin means beingretractable between a first engaging position for engaging said surgicalneedle in a precisely oriented position, and a second non-engagingposition for releasing said surgical needle from its grip thereof. 19.The needle and suture threading and swaging machine according to claim18, wherein said needle gripping means includes means for retracting oneof said plurality of pin means between said first engaging position andsaid second non-engaging position.
 20. The needle and suture threadingand swaging machine according to claim 1, wherein said funnel guidemeans includes a tapered opening having a suture exit diameter that isequal to or greater than the diameter of said suture strand and smallerthan the diameter of the suture receiving opening defined in the needle.21. The needle and suture threading and swaging machine according toclaim 20 wherein said funnel guide means includes a first fixed suturealignment die having an end thereof defining a portion of said taperedopening of said funnel guide means, and a second movable suturealignment die having an end thereof defining another portion of saidtapered opening of said funnel guide means, wherein said second movablesuture alignment die is positioned next to said first fixed suturealignment die to form said tapered opening of said funnel guide means.22. The needle and suture threading and swaging machine according toclaim 21 wherein said funnel guide means includes a registration meansfor engaging said second movable suture alignment die with said secondswaging die for concurrent movement therewith.
 23. The needle and suturethreading and swaging machine according to claim 1 further includingmeans for stiffening a portion of said suture strand in a stiffeningzone located adjacent said first position while said suture is undertension.
 24. The needle and suture threading and swaging machineaccording to claim 23 further including bottom gripping meansreciprocable along said suture axis from said first position to saidinsertion zone,wherein said definite length suture strand is supportedat said free end at said insertion zone by said lead gripping meansafter cutting thereof, and said suture of indefinite length beinggripped between said stiffening zone and said cutting means by saidbottom gripping means.
 25. A needle and suture threading machine forautomatically threading and swaging a surgical needle having a suturereceiving opening formed therein, said machine comprising:(a) first andsecond gripping means for gripping and advancing a suture strand undertension from an indefinite length supply of suture material, each ofsaid gripping means reciprocating along a common suture axis form astiffening zone to an insertion zone; (b) means for cutting said suturestrand in said stiffening zone to create a suture of definite lengthsupported by said first gripping means and a suture of indefinite lengthsupported by said second gripping means; (c) indexing means forpositioning said needle between first and second swaging dies with saidsuture receiving opening aligned with said suture axis; (d) a funnelguide means positioned in the insertion zone between a free end of saiddefinite length suture and said needle, said funnel guide means having aregistration means for aligning it with at least one of said swagingdies; (e) means for advancing said first gripping means along the sutureaxis to direct the free end of the definite length suture through saidfunnel guide means and into the suture receiving opening formed in saidneedle; and (f) swaging means for advancing at least one of said firstand second swaging dies to swaging said needle about the suture.